TOPLINE

Treatment-naive patients with chronic lymphocytic leukemia (CLL) who received acalabrutinib monotherapy had sustained clinical benefit at 3 years, with real-world progression-free survival and overall survival exceeding 80%. Most patients remained on therapy, although some stopped treatment because of adverse events.

METHODOLOGY

• Researchers analyzed 3-year follow-up data from an ongoing observational study (EPIC) in the UK to evaluate the real-world effectiveness and safety of first-line acalabrutinib in patients with CLL.
• The analysis included 282 treatment-naive adult patients (median age, 73.9 years; 55% men) treated at multiple centers across England and Wales who received their first dose between April 2020 and April 2021.
• Patients received acalabrutinib monotherapy, with most starting at 200 mg per day (100 mg twice daily); dose reductions and temporary interruptions were recorded.
• The primary endpoint was real-world progression-free survival. Secondary endpoints included real-world overall survival and time to treatment discontinuation; adverse events were also recorded.
• Patients were followed for a median duration of 48.9 months.

TAKEAWAY

• At 36 months, real-world progression-free survival was 82.5%, and overall survival was 84.3%.
• Treatment interruptions occurred in 41% of patients, with a median time to first interruption of 13.9 months; the most common reasons were adverse events (56%) and minor operations (15%).
• Overall, 31% of patients discontinued acalabrutinib treatment. The most common reasons were adverse events, death, and disease progression.
• The most frequently recorded adverse events were upper respiratory tract infection (8%), neutropenia (4%), cardiovascular-related events (4%), fatigue (4%), and rash (5%).

IN PRACTICE

"[The] findings are consistent with the ELEVATE-TN trial and provide valuable evidence for clinical decision-makers into the real-world use of acalabrutinib in the United Kingdom, with 5-year follow-up analyses planned to further inform long-term outcomes," the authors of the study wrote.

SOURCE

The study was led by Toby A. Eyre, Oxford University Hospitals NHS Foundation Trust in Oxford, United Kingdom. It was published online on July 15 in Blood Advances.

LIMITATIONS

The study involved potential selection bias. Data derived from chart reviews may have introduced bias. The study lacked complete molecular characterization, which prevented direct comparison with clinical trial populations.

DISCLOSURES

The study received funding from AstraZeneca. Multiple authors reported consulting fees, honoraria, research support, or travel support from AstraZeneca and other pharmaceutical companies. Three authors reported being employees and shareholders of AstraZeneca. One author reported being an employee of OPEN Health. Additional author disclosures are reported in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.